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Document Control Manager

Celcuity
USA
Full-time
Manager
Onsite
Discovered 1 weeks ago

Full Job Posting

Responsibilities

  • Facilitates the meticulous creation, revision, and retirement of controlled documents in the eDMS, including managing and tracking Document Change Control workflows and participants
  • Management and migration of legacy files into the eQMS
  • Coordinates with the Training Admin to create new or revisions to Training Requirements, learners, quizzes, and other training related to controlled documents
  • Helps eDMS users with the how-to of document creation and revision and works with the QMS Admin to keep relevant document control SOPs and Work Instructions up to date
  • Helps eDMS users find and use current effective documents
  • Facilitates meetings with the QMS Admin and document reviewers to complete content creation or revisions
  • Manages GxP record retention and destruction tasks
  • Facilitates Certified Copy creation and retention
  • Other duties as assigned.

Qualifications

  • Bachelor’s degree in the life sciences, chemistry, or related field; or relevant experience
  • Five plus (5+) years of experience in document control in a pharmaceutical company, or a related area
  • Proficiency and experience with electronic document management systems, Veeva strongly preferred
  • Knowledge of version control practices and document lifecycle workflows
  • Familiarity with industry standards such as FDA 21 CFR Part 11, ISO 9001, GMP
  • Strong attention to formatting, process, and metadata tagging; ability to create and correct Styles in Word strongly preferred
  • Document auditing and compliance tracking capabilities
  • Excellent written and verbal communication skills, with ability to influence and build credibility at all levels
  • Strong interpersonal skills for interacting with employees and leaders across various levels and functions
  • Attention to detail and ability to manage multiple processes and documentation requirements
  • Strong technical and analytical skills with advanced knowledge in MS Office including Word, Excel, and PowerPoint
  • Ability to work in a team or independently as required
  • Outstanding organizational skills with the ability to prioritize
  • Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment
  • Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization
  • Flexible and willing to learn; adapting to business and site needs in a dynamic environment
  • Maintain a positive, approachable, and professional attitude

Preferred Qualifications

  • Proficiency and experience with electronic document management systems, Veeva strongly preferred
  • Strong attention to formatting, process, and metadata tagging; ability to create and correct Styles in Word strongly preferred

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